Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript
CDRH’s new strategic priorities mean equally big changes for you over the next few years. Want to get ready now?
When the FDA’s Center for Devices and Radiological Health (CDRH) released its 2022-2025 Strategic Priorities, it was giving you a window into the regulatory process changes likely to be implemented through 2025. If you didn’t know that — or weren’t sure how to interpret them — no worries: this presentation will explain it.
Jessica Ringel, a partner in King & Spalding’s FDA & Life Sciences practice group, will walk you through CDRH’s three key initiatives — Promote a Modern and Diverse Workforce, Enhance Organizational Agility and Resilience, and Advance Health Equity — and provide insights into the likely regulatory adjustments to come from them.
The result? You can begin to alter your CDRH interactions and advocacy efforts and adjust your internal processes now, so you’re ready for what’s in store. You may need to modify the design of your clinical trials and your regulatory submissions, for starters.
Ms. Ringel will clarify the center’s new goals, providing an understanding you can use to accommodate the likely changes.
She’ll also show you how CDRH employed process and policy changes to achieve its 2018–2020 Strategic Priorities and the pandemic-related extension into 2021. By connecting those goals to how the alterations affect your regulatory dealings today, she’ll reveal where the current priorities may lead.
- CDRH’s strategic priorities for the next three years and how the center could translate them into regulatory action
- How CDRH’s priority for advancing health equity could affect the design of your devices and clinical trials
- How to increase your chances of regulatory success by understanding the challenges and pressures faced by CDRH staff and improving your interactions with the FDA
- How CDRH’s priorities from prior years changed FDA processes
- An understanding of CDRH’s Breakthrough Devices program, December 2018 guidance and metrics for the program and how these may have helped the FDA meet its 2018–2020 Novel Technologies goal
Don’t miss out on the modifications you need to make to adapt to CDRH’s new priorities and stay compliant.
Meet Your Presenter
Jessica Ringel is a partner in King & Spalding’s FDA & Life Sciences practice group. She advises medical device companies on matters across the spectrum of FDA regulation, with a focus on postmarket safety and quality matters, including responses to FDA inspections and enforcement actions, conducting recalls and reporting adverse events. Ms. Ringel also advises companies on FDA-compliant promotional practices. Her premarket practice includes identifying marketing pathways and the preparation of premarket submissions to the FDA. In addition, Ms. Ringel frequently conducts due diligence evaluations for life sciences manufacturers, private equity funds and investment banks.
Who Will Benefit
- Regulatory department staff
- R&D staff
- Technical writing staff
- Quality audit staff
- General scientists in the pharmaceutical industry
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June 22, 2022